| 17 Aug 2018 | Pasta Spinach with Cavatappi, Reser's Fine Food, item # 71117.14163, 2/4.5 # packages. UPC 0 71117 14163 4. Product is pasta salads with vinaigrette dressings and vegetables including spinach. All products are in white plastic tubs with labeled lids packed 2/4.5 # to a corrugated case. Product is not labeled for… | Reser's Fine Foods, Inc. | Food | Class II | 4 |
| 16 Aug 2018 | Spinach Chopped 1", item # 73039. packaged in plastic bag, each case contains 2/5# bags, There are case labels and no unit label. UPC on case label 0 20728 73039. The case label is read in part: "***SPINACH CHOPPED 1" *** 2/5#***73039***PACIFIC COAST FRUIT, PORTLAND, OR 97232***Keep Refrigerated***. | Pacific Coast Fruit Company | Food | Class II | 1 |
| 15 Aug 2018 | Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9 | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 14 Aug 2018 | Valsartan Tablets USP, 40 mg, 30-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-360-30 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 4 |
| 14 Aug 2018 | Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class III | 1 |
| 14 Aug 2018 | Chocolate Gooey Brownie Ice Cream, packaged in pint-sized containers (473 mL), net wt 378 g; 1 gal. container, or 3 gal. tubs. 3 gal. tubs were sold to Salt & Straw Retail Scoop Shops only. 1 gal. containers are sold to wholesale accounts only. Event 80815 | SALT & STRAW LLC | Food | Class I | 1 |
| 13 Aug 2018 | Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 10 Aug 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19 | RemedyRepack Inc. | Drug | Class II | 3 |
| 9 Aug 2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99. Event 80801 | Orexigen Therapeutics, Inc. | Drug | Class III | 1 |
| 8 Aug 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307 | Hetero Labs Limited Unit V | Drug | Class II | 4 |
| 7 Aug 2018 | Boar's Head Brand Sweet Vidalia Onions in Sauce, glass jars 9oz UPC 0 42421 06956 3 & 64 oz UPC 0 42421 26517 0. DISTRIBUTED BY: BRUNCKHORST CO., NY, NY 11206-3886 Event 80678 | Vidalia Valley, Inc. | Food | Class II | 1 |
| 7 Aug 2018 | BLUE GREEN ALGAE: Packaged under the following brands: AMERICAN HEALTH KALMATH SHORES BLUE GREEN ALGAE, 120 CAPSULES, UPC: 0 76630 02542 3 and Puritan's Pride PREMIUM Kalamath Lake Blue Green Algae, 500 MG, 120 RAPID RELEASE CAPSULES, UPC 0 74312 12542 3 Event 80781 | Natures Bounty Inc | Food | Class II | 1 |
| 7 Aug 2018 | Graeter's HANDCRAFTED French Pot ICE CREAM, Limited Edition KEY LIME PIE**ONE PINT (473 ml)**Nutrition Facts**GLUTEN FREE**INGREDIENTS: CREAM, MILK, CANE SUGAR, GRAHAM PIE PIECES, WHEAT FLOUR**CONTAINS:MILK, EGG, WHEAT,& SOY**Manufactured by: Graeter's Ice Cream, Cincinnati, OH** Event 80783 | Graeters Manufacturing Company | Food | Class II | 1 |
| 6 Aug 2018 | TROPICAL PEPPER CO. Crushed Chili Pepper Sauce, 11.5 FL. OZ. (325ml), PRODUCT OF COSTA RICA, Packed Exclusively for: H.L. Benndorf Corp. Medford, NJ 08055 | Alimentos Kamuk Internacional (Costa Rica) S. A. | Food | Class II | 2 |
| 6 Aug 2018 | BEST TASTE BRAND SNACK GINGER SLICED, Net Weight 200g, 7 OZ, Distributed by; COUNTRY FAVOR., INC U.S.A; PRODUCT OF VIETNAM | Country Favor Inc. | Food | Class I | 1 |
| 6 Aug 2018 | BulkSupplements.com Glucosamine Sulfate Potassium; 100 grams, 250 grams, 500 grams, 1 kilogram; Stand up zipper pouch bags. Directions: As a dietary supplement, take 1000 mg (scant 1/4 tsp) up to three time daily, or as directed by a physician. Distributed exclusively by: Bulk Supplements.com 7511 Eastgate Road… Event 80770 | Hard Eight Nutrition LLC | Food | Class II | 1 |
| 6 Aug 2018 | Summer squash noodles packaged under the following brands - the PICK UPC: 8 54340 00706 5 | Banks Square Market Corp dba The Produce Connection | Food | Class II | 3 |
| 3 Aug 2018 | MOSAIQ Oncology Information System | Elekta, Inc. | Device | Class II | 1 |
| 3 Aug 2018 | Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02 Event 80753 | Huijing (Shanghai) Bio-tech Co., Ltd. | Drug | Class III | 1 |
| 3 Aug 2018 | Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04. | Westminster Pharmaceuticals LLC | Drug | Class I | 5 |
| 3 Aug 2018 | FUSIA Asian Inspirations Spicy Mongolian Noodle Bowl, NET WT 8.5 OZ (240g) Heat and Serve UPC# 041498135461 PRODUCT OF CHINA Event 80721 | Marketing Concepts Group | Food | Class II | 1 |
| 3 Aug 2018 | Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable Blend, Net Wt. 15 lbs (6 / 2.5 lb bags per case), UPC 1007117012948, Distributed by JR Simplot Co. PO Box 9386, Boise, ID 83707. Product is frozen. The label is read in parts: "***EXOTIC GRAINS & FIRE-ROASTED VEGETABLE BLEND ***Red & brown rice, black beans,… | J R Simplot Co Corporate HQ | Food | Class II | 1 |
| 3 Aug 2018 | Mediterranean Salad Vegan, pre-packaged. UPC 0 211004 706991. | Market of Choice Inc | Food | Class II | 1 |
| 2 Aug 2018 | Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05 Event 80675 | Name withheld | Drug | Class III | 1 |
| 2 Aug 2018 | Sunny Side Farms Peanut Butter Cup Ice Cream; 48 oz. carton, 1.5 QTS (1.42L) UPC: 7-17544-20740 5 Allergens for Peanut Butter Cup: Milk, Peanuts, Soy, Coconut. Allergens for Butter Pecan: Milk, Pecans Both packages include the following statement: While best practices and preventive measures are taken to control… Event 80705 | Super Store Industries-Turlock Dairy Division | Food | Class II | 1 |
| 1 Aug 2018 | Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24. | Baxter Healthcare Corporation | Drug | Class III | 3 |
| 1 Aug 2018 | Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30 | Akorn, Inc. | Drug | Class II | 1 |
| 1 Aug 2018 | Sweet Earth Foods Aloha BBQ Quesadilla; 2 pack, NET WT 8 oz. Vegan: Pinto Beans, Red Onions, Pineapple and jalapenos with our vegan BBQ grounds and a cheddar-style vegan cheese. Keep Frozen. Ingredients: Filling: Vegan BBQ savory grounds (water, vital wheat gluten, onion, soy sauce, (water, soybeans, wheat, salt,… Event 80679 | Sweet Earth Inc. | Food | Class I | 1 |
| 1 Aug 2018 | Dole Classic Coleslaw, 14 oz. (397 g) plastic bag; Green Cabbage, shredded carrots. UPC Code 7143001066 Distributed by Dole Fresh Vegetables, Inc., Monterey, CA Case - 10.5 lbs - 12-14 oz. bags. (01) 20071430010666; (10) 2012006212W 8653 | Dole Fresh Vegetables Inc | Food | Class II | 1 |
| 1 Aug 2018 | Blue Diamond Almond Breeze Almond Milk, Half Gallon | HP Hood LLC | Food | Class I | 1 |
| 30 Jul 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04 | MAJOR PHARMACEUTICALS | Drug | Class II | 1 |
| 30 Jul 2018 | Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9 | NuCare Pharmaceuticals Inc | Drug | Class II | 3 |
| 30 Jul 2018 | Driscoll's Only the Finest Berries; Strawberries Fraises; NET WT 16 oz. (1 lb.) Product of the USA Driscoll Strawberry Associates, Inc. Watsonville, CA 95077 Event 80673 | Driscoll's Strawberry Associates, Inc. | Food | Class II | 1 |
| 27 Jul 2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504. | Bryant Ranch Prepack Inc. | Drug | Class II | 3 |
| 27 Jul 2018 | Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White 150cc HDPE Bottle with Desiccant and white cap, packed as 12 bottles / shipper case Event 80661 | Seroyal International, a division of Atrium Innovations | Food | Class II | 1 |
| 27 Jul 2018 | Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches, 4/6 oz, and 18/6 oz. | Lipari Foods, Inc. | Food | Class I | 1 |
| 27 Jul 2018 | TeaSource Roasted Chestnut, loose leaf tea. packaged in 16 oz. (454g)Metal/Poly non-resealable bag, and 4 oz., and 2 oz. resealable foil bags. teasource.com, 2616 Cleveland Ave N, Roseville, MN 55113. Event 80647 | Teasource | Food | Class II | 1 |
| 26 Jul 2018 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 26 Jul 2018 | Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side. | H J Harkins Company Inc dba Pharma Pac | Drug | Class II | 1 |
| 26 Jul 2018 | Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361 | Right Value Drug Stores, Inc. | Drug | Class III | 1 |
| 26 Jul 2018 | Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing. 12 oz glass bottle, 6 bottles per case Shelf Stable and Refrigerate After Opening UPC 0021000068876 | KRAFT HEINZ FOODS COMPANY | Food | Class III | 1 |
| 26 Jul 2018 | FP0392, Confidence, Glucosamine Plus, with White Willow Bark & Boswella, 90 Extended Release Tablets, UPC# 8 10891 02253 7 | Confidence Inc./Confidence U.S.A. Inc. | Food | Class II | 4 |
| 25 Jul 2018 | Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 25 Jul 2018 | Atropine 0.01% Opth Solution, 5 mL droptainer, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644. | Ranier's Compounding Laboratory | Drug | Class II | 15 |
| 25 Jul 2018 | alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5 | The Hain Celestial Group, Inc. - Worldwide HQ | Drug | Class II | 1 |
| 25 Jul 2018 | Severino Home Made, Artisanal Small Batch Pasta, Raviolini Cheese, 9 units x 9 oz per case. Expiration March 2019. Event 80677 | Severino Pasta Manufacturing, Inc. | Food | Class III | 1 |
| 25 Jul 2018 | BANTAM BAGELS The Classic Mini Stuffed Bagels PLAIN BAGEL STUFFED WITH PLAIN WHIPPED CREAM CHEESE with large white sticker on the front of the packaging that states EGG TEST 5/04/2018, Frozen Event 80714 | Name withheld | Food | Class II | 1 |
| 24 Jul 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50. | West-Ward Columbus Inc | Drug | Class II | 2 |
| 24 Jul 2018 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08. | Morton Grove Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 24 Jul 2018 | 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC. | PharMEDium Services, LLC | Drug | Class II | 3 |
| 24 Jul 2018 | Taco Bell Salsa Con Queso Mild 15oz retail jar UPC 21000024490 packaged in 12 count and 8 count cases | KRAFT HEINZ FOODS COMPANY | Food | Class II | 1 |
| 24 Jul 2018 | Matiz Raw Apricot Bar Demi-luna 8.8 ounces bar, packaged in shrink wrap plastic, UPC 8 32924 00543 0. Product is labeled in parts: "***matiz RAW APRICOT ***100% Natural Ingredients: 92% dried apricots and almonds ****PRODUCED BY: Bio Vera, Losar de la Vera, Cceres***product of Spain*** Imported by Matiz España,… | Power Selles Imports dba Culinary Collective | Food | Class II | 1 |
| 23 Jul 2018 | Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased… | Johnson & Johnson Vision Care, Inc. | Device | Class II | 1 |
| 23 Jul 2018 | Organic Dried Figs 6X16oz (454g), UPC 8 77693 00850 3 Event 80756 | Prana Biovegan Inc. | Food | Class III | 1 |
| 23 Jul 2018 | Vitale Brothers Rye bread (1lb loaf) UPC1589410007 | Vitale Brothers Bakery,Inc. | Food | Class II | 5 |
| 23 Jul 2018 | Pepperidge Farm Goldfish Baked Snack Crackers Flavor Blasted Xtra Cheddar in the following sized containers: 1. Net Wt. 6.6 oz. (187g) bag, UPC 14100-08548; 2. Net Wt. 30 oz. (1.87 lbs) 850g) carton, UPC 14100-09658; 3. 9 Lunch Packs, Net Wt. 8.1 oz (230g) Multi-pack Tray, 9-count 0.9 oz. Snack Pack, UPC 14100-09654;… | Pepperidge Farm, Incorporated | Food | Class II | 8 |
| 21 Jul 2018 | RITZ BITS CHEESE BIG BAG 3 Oz, Pouch Retail: 12 per case Foodservice: 36 per case | Mondelez Global Llc | Food | Class II | 13 |
| 20 Jul 2018 | Sweet Serenity Caramel Sea Salt Chocolate Chip Cookies, with caramel flavored chips; NET WT; 2 oz. UPC: 0 31535 59962 2 Manufactured by Biscomerica Corp, Rialto, CA Ingredients: Enriched unbleached flour (wheat flour, niacin, reduced iron, thiamine mononitrate {Vitamin B1}, Riboflavin {Vitamin B2} Folic acid),… Event 80576 | Biscomerica, Inc. | Food | Class II | 1 |
| 20 Jul 2018 | Cauliflower Pilaf with Fresh Turmeric and Fennel, New Seasons Kitchen Collective Meal Kits, Net wt. 2 lb 4 oz (1007 gr), UPC 840600109563. The ingredients statement of the finished product package is labeled in parts: ***INGREDIENTS: Cauliflower, Water, Fennel, Onion, Lemon Juice, Golden Raisins, Fresh Turmeric Root,… | New Seasons Market LLC | Food | Class III | 1 |
| 20 Jul 2018 | Ruffles Original potato chips 9 oz. bags | Frito-Lay, Inc | Food | Class III | 2 |
| 20 Jul 2018 | Homestyle Seasoned Croutons: 4 oz. foil pouch Item # 73689 UPC 10083661736898 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047 | Sugar Foods Corporation Inc | Food | Class II | 10 |
| 20 Jul 2018 | Sherman Candy Caramels are individually wrapped in plastic and then sealed in a cardboard flexible carton. Each Sherman Candy Caramels contains 3 pieces inside and sold in the following gift baskets: Metropolitan Gourmet Gift Basket. Encore Gourmet Gift Basket. Toast of California Wine Basket. California Classic Gift… Event 80588 | Gift Services Inc Warehouse | Food | Class I | 1 |
| 20 Jul 2018 | Peanut Paste/Butter bulk tankers Event 80599 | Peanut Processors, Inc. | Food | Class I | 1 |
| 19 Jul 2018 | Grizzlies Brand and Grizzlies Granolas Oregon Trail Mix consisting of chocolate chips, fruit, seeds, and nuts. Product packaged in a cardboard box with a liner bag, net wt. 20 lbs., and was distributed to retailers for sale from their bulk bins. The product's ingredients statement on the green label is read… Event 80587 | Green Valley Group, LLC | Food | Class I | 1 |
| 19 Jul 2018 | Kauffman's Fruit Farm & Market Sweet Apple Cider; Keep Refrigerated; Kauffman's Fruit Farm, Bird-in-Hand, PA 17505; Enjoy thru 08/02/18. Packed in Net Wt 128 Fl. Oz.; 64 Fl. Oz.; 32 Fl. Oz.; 16 Fl. Oz. and 12 Fl. Oz. Event 80579 | Kauffman's Fruit Farm and Market, Inc. | Food | Class II | 1 |
| 19 Jul 2018 | Food Lion Dill Pickle Flavored Potato Chips 7.75 oz. package bag/12 bags per case | Shearer's Snacks | Food | Class I | 1 |
| 19 Jul 2018 | Pizza Hut Seasoning Breadstick 10 pound case, 5 X 2 lb. packages per case, Case SKU 6025584 UPC 1 0885251 71131 1 Event 80590 | Saratoga Food Specialties, Inc. | Food | Class II | 1 |
| 18 Jul 2018 | Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01. | VENSUN PHARMACEUTICALS INC | Drug | Class II | 2 |
| 18 Jul 2018 | Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854; By: Hetero, Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India; NDC 31722-543-01. Event 80589 | Name withheld | Drug | Class II | 1 |
| 18 Jul 2018 | Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. | MAJOR PHARMACEUTICALS | Drug | Class II | 2 |
| 18 Jul 2018 | Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52 | Northwind Pharmaceuticals LLC | Drug | Class II | 4 |
| 18 Jul 2018 | Only 8 Vanilla Yogurt 2.8 pound pouch 6 pouches per case | Subco Foods Inc. | Food | Class II | 2 |
| 18 Jul 2018 | Swiss Rolls***Brand Name**Swiss Rolls Chocolate (Snack) Cakes, NET WT OZ (g) PKGS***TWIN PACKS***Nutrition Facts***Ingredients: SUGAR, WHEY (MILK), ENRICHED BLEACHED FLOUR***DISTRIBUTED BY***UPC Sold under the brand names... Mrs. Freshley's - NET WT 12 OZ (340g) 6-2 OZ (57g) PKGS***Distributed by Flowers Foods… | FLOWERS FOODS | Food | Class II | 2 |
| 18 Jul 2018 | HEB Creamy Creations Orange and Lime Sherbet Cup 3 oz packaged in a 12 count plastic bag - (6-3oz. Orange Flavored Sherbet cups and 6-3oz. Lime Flavored Sherbet cups) | H-E-B GROCERY COMPANY LP DBA HEB | Food | Class II | 2 |
| 18 Jul 2018 | #7024 Chill Do 24 (whey, corn flour, l-cysteine, potassium bromate); Packaged in 50-lb paper bag. Event 80608 | Brolite Products Inc | Food | Class II | 1 |
| 18 Jul 2018 | Ocean Delight Individually Vacuum Packed AHI TUNA SAKU, 8-12 oz. NET WT. 10 LB (4.54 kg) and 12-16 oz. NET WT. 22LB (9.98 kg), Carbon Monoxide Treated, DISTRIBUTED BY: Stavis Seafoods, WILD CAUGHT, PRODUCT OF SRI LANKA Event 80560 | Stavis Seafoods, Inc. | Food | Class III | 1 |
| 18 Jul 2018 | GU Energy Gels: Birthday Cake, Gel; GUGEL 1 Pkt; item # 124418, UPC 769493102843; GUGEL 8Pkt Box, item number 124419, UPC: 769493102850; GUGEL 24Pkt Box; item number 124417, UPC 769493102836. | Advanced Food Concepts | Food | Class III | 43 |
| 17 Jul 2018 | Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701 | RemedyRepack Inc. | Drug | Class II | 2 |
| 17 Jul 2018 | Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY | Longbow First Aid Products Manufactory | Drug | Class II | 2 |
| 17 Jul 2018 | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China | A-S Medication Solutions LLC. | Drug | Class II | 4 |
| 17 Jul 2018 | Butter Toffee Flavored Hazelnuts, packaged in a clear plastic bag, net wt 6 oz. UPC 7 39059 30612 1. The label is read in parts: "***Butter Toffee Flavored Hazelnuts *** Ingredients: Dry Roasted Hazelnuts, Sugar, Butter, Sea Salt and Natural Vanilla Extract *** Contains Dairy. | Holmquist Hazelnut Orchards | Food | Class II | 2 |
| 17 Jul 2018 | Natural Flavor Turkey Type, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient | Name withheld | Food | Class II | 4 |
| 17 Jul 2018 | Seattle Sourdough Pub Buns 6 pack, net wt. 16 oz., UPC 0-72220-10164-5 | Portland French Bakery L T D | Food | Class I | 2 |
| 17 Jul 2018 | Cracker Barrel OLD FASHIONED COUNTRY CANDIES KETTLE COOKED FUDGE PEANUT BUTTER, Nutrition Facts***INGREDIENTS: SUGAR, PEANUT BUTTER***PACKED ESPECIALLY FOR CRACKER BARREL OLD COUNTRY STORE, LEBANON, TENNESSEE 37067*** Event 80564 | Country Fresh Food & Confections Inc. | Food | Class II | 1 |
| 17 Jul 2018 | Biscuit Mix 4.5 pound bag, 8 bags per carton Item 127042301 | Griffith Labs U.S.A. | Food | Class II | 43 |
| 16 Jul 2018 | CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in… | In2bones USA, LLC | Device | Class II | 2 |
| 16 Jul 2018 | Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 16 Jul 2018 | Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19. | Teva Pharmaceuticals USA | Drug | Class II | 9 |
| 16 Jul 2018 | AMPI Whey Powder, Sweet Type, Formula 521, Extra Grade, spray process pasteurized, packaged in 50 lbs net (22.68 kg net) and 25 kg net (55.12 lbs net). Event 80537 | AMPI | Food | Class II | 1 |
| 16 Jul 2018 | Cheerios Protein Oats & Honey, Packaged in the following sizes: Net Wt. 19 oz. (583g) UPC 16000-44473. 12 boxes/case, Net Wt. 14.1 oz. (399g) UPC 16000-45137. 16 boxes/case. Dist. By General M ills Sales, Inc., Minneapolis, MN 55440 USA. | General Mills, Inc | Food | Class II | 1 |
| 16 Jul 2018 | Hy-Vee Spring Pasta Salad packaged in the following containers: 1) plastic tubs with lids, Net Wt 16 OZ (454 g); 2) plastic tubs with lids, Net Wt 48 OZ (3 LB) 1.36 kg; 3) 4/8 lb cases Net Wt 32.00 LBS (14.51 KG); 4) 8 lb cases Net WT. 8.00 LBS (3.63 KG); 5) 11 lb Spring Salad Kit, 11.00 LBS (4.99 KG); and 6) clear… | D & D Foods, Inc. | Food | Class I | 1 |
| 14 Jul 2018 | utz Carolina Style Barbeque Potato Chips, Net Wt 2.875 OZ, UTZ Quality Foods, LLV, Hanover, PA 17301, UPC: 0-41780-00153-5; utz Carolina Style Barbeque Potato Chips, Net Wt 7.5 OZ; UTZ Quality Foods, LLV, Hanover, PA 17301; UPC: 0-41780-00049-1 | Utz Quality Food Inc | Food | Class I | 1 |
| 14 Jul 2018 | AnnaSea Wasabi Ahi Poke Hawaiian Poke Kits | Aldi Inc | Food | Class II | 2 |
| 13 Jul 2018 | Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to… | Philips Electronics North America Corporation | Device | Class II | 5 |
| 13 Jul 2018 | Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03 | Prinston Pharmaceutical Inc | Drug | Class II | 9 |
| 13 Jul 2018 | Fresh Peach Parfait , 1.0 Pound | Whole Foods Market Group Inc. | Food | Class I | 19 |
| 13 Jul 2018 | Diet Pepsi 7.5 oz cans, 6-pack. UPC on case label is 0 12000 16314 2. The product's case label is read in parts: "***diet pepsi***CARBONATED WATER, CARAMEL COLOR, PHOSPHORIC ACID, POTASSIUM BENZOATE (PRESERVES FRESHNESS), SUCRALOSE, ACESULFAME POTASSIUM, CAFFEINE, NATURAL FLAVOR, CITRIC ACID***" | Pepsico Inc | Food | Class III | 1 |
| 13 Jul 2018 | Europe's Best 4-Field Berry Mix 12/600g and 6/2kg (Blackberries, Strawberries, Blueberries, Raspberries) | Holley Cold Storage Fruit & Produce Co., Inc. | Food | Class I | 3 |
| 12 Jul 2018 | power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only) | Baxter Healthcare Corporation | Device | Class II | 1 |
| 12 Jul 2018 | Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 12 Jul 2018 | naturipe Blueberries, INDIVIDUAL QUICK FROZEN, NET WT 30-LBS cardboard boxes, DISTRIBUTED BY NATURIPE 04726 COUNTY ROAD 215, GRAND JUNCTION, MN 43058 Event 80600 | MBG Marketing | Food | Class I | 1 |
| 12 Jul 2018 | Pictsweet Farms Steam'ables Baby Brussels Sprouts***NET WT 12 OZ (340g)***THIS SIDE UP IN MICROWAVE***Nutrition Facts***INGREDIENTS: BRUSSEL SPROUTS*** | The Pictsweet Company | Food | Class I | 1 |
| 12 Jul 2018 | Soy Honey Cluster 30 lb. case, plastic bag in cardboard box Product code 30666529.137 | Kerry Inc | Food | Class II | 1 |
| 12 Jul 2018 | Kowalski's Markets kalbi rub. Net Wt 5.5 oz. (155.9 g), UPC 79147-00243. Distributed by: Kowalski's Markets, Woodbury, MN 55125 Event 80514 | J and J Bunting, Inc | Food | Class II | 1 |
| 11 Jul 2018 | Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of… | Spacelabs Healthcare, Ltd. | Device | Class I | 1 |
| 11 Jul 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06. | Renaissance Lakewood, LLC | Drug | Class III | 3 |
| 11 Jul 2018 | JouJou's white large pita bread Event 80546 | Constantine's International Foods | Food | Class II | 1 |
| 11 Jul 2018 | Superfood Salad Kit - 6.8 lbs. - sold to Kroger owned stores and prepared and purchased at deli department at retail stores. Size purchased is dependent on customer order. 6.8 lb. kit UPC: 7 82796 0174 3 Fry's, King Sooper;Smith's Food and Drug: UPC 2541465XXXX - last 4 digits are price of product.; Ralph's UPC… Event 80509 | Papa John's Salads & Produce, Inc. | Food | Class II | 1 |
| 10 Jul 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer. | Arrow International Inc | Device | Class II | 2 |
| 10 Jul 2018 | Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT… | Valeant Pharmaceuticals North America LLC | Drug | Class III | 1 |
| 10 Jul 2018 | Thunderbird Bars 1.7 oz Pecan Goji Pistachio Bar (case of 120) | APOGEE FOODS | Food | Class II | 2 |
| 9 Jul 2018 | Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator | Sorin CRM SAS | Device | Class II | 2 |
| 9 Jul 2018 | Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045 | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 9 Jul 2018 | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder of drug product. Functionality of the… Event 80555 | INO therapeutics LLC/dba ikaria | Device | Class II | 1 |
| 5 Jul 2018 | Canned Salmon in unlabeled 8oz metal cans. Cans are packaged into a case of 92 cans. The case label is read: "Canned Salmon***Product of U.S.A. Net. Wt. 62 lbs. Packed by: Faith Harvest Helpers 12643 Case Rd SW Olympia, WA 98512***" Event 80461 | YWAM Faith Harvest Helpers | Food | Class II | 1 |
| 5 Jul 2018 | SPARKLING GRAPEFRUIT JUICE DRINK, 6/34 oz., glass bottles | Gourmet International Inc. | Food | Class II | 6 |
| 3 Jul 2018 | AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301 AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of… | ConvaTec, Inc | Device | Class II | 1 |
| 3 Jul 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against… | Arrow International Inc | Device | Class II | 1 |
| 3 Jul 2018 | PINK LEMONADE COOKIES Byrd's FAMOUS COOKIES; NET WT. 7 OZ .(198g) BOX; BYRD COOKIE COMPANY 6700 WATERS SAVANNAH, GA 31406 800-291-2973; UPC 7 48829 04946 5 Event 80447 | Byrd Cookie Co | Food | Class III | 1 |
| 2 Jul 2018 | iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements. Event 80483 | Hudson Scientific LLC | Device | Class II | 1 |
| 2 Jul 2018 | Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and… Event 80474 | Water Pik, Inc. | Device | Class II | 1 |
| 2 Jul 2018 | Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers. | Cypress Medical Products LLC | Device | Class II | 1 |
| 29 Jun 2018 | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where… | Integra LifeSciences Corp. | Device | Class II | 4 |
| 29 Jun 2018 | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post… | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 29 Jun 2018 | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or… Event 80639 | Back 2 Basics Direct LLC | Device | Class II | 1 |
| 29 Jun 2018 | 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product Usage: The ceiling stand is used to hold the X-ray tube and / or the detector and is moveable on a ceiling rail system in three axis. The tube and / or detector can be rotated above a horizontal and a vertical axle. The ceiling stand can be used… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 29 Jun 2018 | MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation. | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 29 Jun 2018 | Prescript-Assist Broad Spectrum Probiotic & Prebiotic Gastrointestinal Support Dietary Supplement, 60-capsule or 90-capsule bottles; UPC Codes: 853956003157, 853956003539 Event 80419 | LL'S MAGNETIC CLAY INC | Food | Class I | 1 |
| 29 Jun 2018 | Sisel, SiselRipt, postWORKOUT, Dietary supplement, net wt 5g (0.17 oz), Internal Company Number F137315-10-01 Event 80398 | Sisel International Llc | Food | Class III | 1 |
| 29 Jun 2018 | 3+2 Soda Crackers (CREAM FLAVOUR)(S) packaged in a 4.4 oz, yellow package, UPC: 6 919892 633101 Event 80432 | May Flower International Inc. | Food | Class I | 1 |
| 28 Jun 2018 | The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. | Datex-Ohmeda, Inc. | Device | Class II | 1 |
| 28 Jun 2018 | Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device. Event 80489 | Envoy Medical Corporation | Device | Class II | 1 |
| 28 Jun 2018 | Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01. | PFIZER | Drug | Class II | 1 |
| 28 Jun 2018 | Fresh Cilantro: Boxed by Sabor Farms, Salinas, CA 60 bunches of cilantro per box Event 80426 | Name withheld | Food | Class I | 1 |
| 27 Jun 2018 | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S | Stryker GmbH | Device | Class II | 1 |
| 27 Jun 2018 | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 | Philips Medical Systems Gmbh, DMC | Device | Class II | 28 |
| 27 Jun 2018 | Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India. NDC: 33261-0977-90 | Aidarex Pharmaceuticals LLC | Drug | Class III | 3 |
| 26 Jun 2018 | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users. | Encore Medical, Lp | Device | Class II | 1 |
| 26 Jun 2018 | CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 26 Jun 2018 | Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3 | World Organix, LLC | Drug | Class I | 5 |
| 26 Jun 2018 | Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054; Distributed by: MAJOR Pharmaceuticals, 17177 N… | MAJOR PHARMACEUTICALS | Drug | Class III | 2 |
| 25 Jun 2018 | Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 22 Jun 2018 | Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 22 Jun 2018 | Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 22 Jun 2018 | Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite… Event 80535 | Clarity Diagnostics Llc | Device | Class III | 1 |
| 22 Jun 2018 | Amino Life brand Product - L-Leucine Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner | Prinova US LLC | Food | Class III | 4 |
| 21 Jun 2018 | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 21 Jun 2018 | BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi. | Becton Dickinson & Co. | Device | Class II | 1 |
| 20 Jun 2018 | The Tri-Flo Subglottic Suction System | Vyaire Medical | Device | Class I | 1 |
| 20 Jun 2018 | Consumer Packaging: WELLSLEY FARM WILD CAUGHT MAHI-MAHI LOINS, UPC: 8 88670 00983 3, plastic 2lb retail bag, Keep Frozen. Master Carton: BJ s Wholesale Club Wild Mahi Mahi Loins Skinless Bone Out 16/2Lb. VP Bags. NET WT. 32 LB. Item Code: 32272, UPC: 0 29714 32727 2. Product of Taiwan. Event 80444 | Orca Bay Foods LLC | Food | Class III | 1 |
| 19 Jun 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024 | Nico Corp. | Device | Class II | 1 |
| 18 Jun 2018 | Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery. Event 80565 | Name withheld | Device | Class II | 1 |
| 18 Jun 2018 | Connecting Bolt, Model 14-442093 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 18 Jun 2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both… | Compass Health Brands (Corporate Office) | Device | Class I | 1 |
| 15 Jun 2018 | Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955 | Covidien LLC | Device | Class II | 1 |
| 14 Jun 2018 | CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 | Abbott Laboratories, Inc. | Device | Class II | 1 |
| 13 Jun 2018 | Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F) in adult and pediatric patients of all ages. | Bard Medical Division | Device | Class II | 1 |
| 13 Jun 2018 | O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. | Beekley Corporation | Device | Class II | 3 |
| 11 Jun 2018 | Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive Event 80533 | Withings Sas | Device | Class II | 1 |
| 11 Jun 2018 | Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker… | Philips Healthcare | Device | Class II | 3 |
| 11 Jun 2018 | NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration. | NxStage Medical, Inc. | Device | Class II | 1 |
| 8 Jun 2018 | Zimmer Dermatone AN, Model No. 88710100 | Zimmer Surgical Inc | Device | Class II | 1 |
| 8 Jun 2018 | PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983) | Ethicon, Inc. | Device | Class II | 3 |
| 8 Jun 2018 | Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. | Randox Laboratories Ltd. | Device | Class II | 1 |
| 8 Jun 2018 | ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem. | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 6 Jun 2018 | RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 6 Jun 2018 | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens.… | Tosoh Bioscience Inc | Device | Class II | 1 |
| 6 Jun 2018 | Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821. | Pharmalucence, Inc. | Drug | Class II | 1 |
| 6 Jun 2018 | LAXMI Corn Flour Fine Net Wt./Poids Net. 2LB (907g) Distributed by: House of Spices (India) Inc. Event 80470 | House Of Spices Orlando | Food | Class II | 1 |
| 6 Jun 2018 | Ruby Red Sockeye Candy (ACA) is cold smoked salmon, 4 oz packages | Name withheld | Food | Class I | 2 |
| 5 Jun 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte… | Tosoh Bioscience Inc | Device | Class III | 1 |
| 4 Jun 2018 | BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries). | CryoLife, Inc. | Device | Class II | 1 |
| 4 Jun 2018 | Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for… | Leica Microsystems, Inc. | Device | Class II | 1 |
| 4 Jun 2018 | EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin. | Richard-Allan Scientific Company | Device | Class III | 1 |
| 31 May 2018 | VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure… | Cook Inc. | Device | Class II | 1 |
| 30 May 2018 | ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 28 May 2018 | EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. Event 80430 | QIAGEN | Device | Class II | 1 |
| 25 May 2018 | AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 24 May 2018 | Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 | GE Healthcare, LLC | Device | Class II | 10 |
| 23 May 2018 | Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation. | Arrow International Inc | Device | Class II | 1 |
| 23 May 2018 | Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological | Ortho Kinematics, Inc | Device | Class II | 1 |
| 18 May 2018 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human… | Guangzhou Wondfo Biotech Co., Ltd. | Device | Class II | 3 |
| 18 May 2018 | Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation. | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Device | Class II | 1 |
| 18 May 2018 | AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women. Event 80404 | Qiagen Sciences, Inc. | Device | Class I | 1 |
| 18 May 2018 | OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The… | OMNIlife science Inc. | Device | Class II | 1 |
| 17 May 2018 | The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 17 May 2018 | Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 | Guardian Pharmacy Services | Drug | Class II | 23 |
| 16 May 2018 | BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jose, CA. The Loader offers various settings to resuspend and mix samples. It can draw from 12 x 75-mm tubes in 30- and… | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 16 May 2018 | HexaPOD evo RT Couch Top (also known as HexaPOD evo Module), a component of the HexaPOD evo RT system. Product Usage: To support and aid in positioning a patient during radiation therapy | Elekta, Inc. | Device | Class II | 1 |
| 15 May 2018 | CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox… Event 80340 | CAREstream Medical LLC | Device | Class II | 1 |
| 15 May 2018 | XLTEK EMU40EX EEG Headbox | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Device | Class II | 1 |
| 15 May 2018 | MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 | Megadyne Medical Products, Inc. | Device | Class II | 1 |
| 14 May 2018 | O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | O-Two Medical Technologies, Inc. | Device | Class II | 1 |
| 10 May 2018 | Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium. | Life Technologies, Corp. | Device | Class II | 6 |
| 10 May 2018 | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical… | Mako Surgical Corporation | Device | Class II | 1 |
| 8 May 2018 | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen… | Vyaire Medical | Device | Class I | 2 |
| 8 May 2018 | Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Event 80296 | Human Design Medical Llc | Device | Class III | 1 |
| 7 May 2018 | cobas m 511 integrated hematology analyzer, Model Number 07261691190 Product Usage: The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a… Event 80376 | Roche Diagnostics Hematology | Device | Class II | 1 |
| 4 May 2018 | MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes. | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 May 2018 | AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are… | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 2 May 2018 | 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV… | Galt Medical Corporation | Device | Class II | 8 |
| 27 Apr 2018 | GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40… | GE Healthcare Japan Corporation | Device | Class II | 4 |
| 17 Apr 2018 | BLAST Bandage, sterile. Event 80157 | Tactical Medical Solutions, Inc. | Device | Class II | 1 |
| 16 Apr 2018 | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna. | TriMed Inc. | Device | Class II | 1 |
| 13 Apr 2018 | Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 12 Apr 2018 | VitalGo Total Lift Bed VG-TLB425T-TQR, Version 71064V0-27003 Event 80495 | Vitalgo Inc. | Device | Class II | 1 |
| 11 Apr 2018 | FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) Event 80353 | Name withheld | Device | Class II | 1 |
| 2 Apr 2018 | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human… | Bio-Rad Laboratories Inc | Device | Class II | 1 |
| 30 Mar 2018 | Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty. | Think Surgical, Inc. | Device | Class II | 1 |
| 30 Mar 2018 | MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole body magnetic resonance images that are high resolution high signal-to-noise ratio, with short scan times. The Signa… | GE Medical Systems, LLC | Device | Class II | 1 |
| 29 Mar 2018 | Access Hi-Low Exam Tables, Model 6501-XX Event 80164 | Brewer Company, LLC | Device | Class II | 1 |
| 16 Mar 2018 | Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit… | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 9 Mar 2018 | Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital. | Hamilton Medical AG | Device | Class II | 2 |
| 1 Mar 2018 | VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay) | bioMerieux, Inc. | Device | Class II | 1 |
| 1 Mar 2018 | 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system. | ICU Medical de Mexico, S.A. de C.V. | Device | Class II | 20 |
| 23 Feb 2018 | CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound… | Civco Medical Instruments Co. Inc. | Device | Class II | 1 |
| 12 Feb 2018 | Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities. | Name withheld | Device | Class II | 2 |
| 7 Feb 2018 | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days… | Medela Inc | Device | Class II | 1 |
| 2 Feb 2018 | 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 1 Feb 2018 | Nicolet Ambulatory EEG | Natus Neurology Inc | Device | Class II | 1 |
| 1 Feb 2018 | SOMATOM Emotion 6 (Model 10165888) | Siemens Medical Solutions USA, Inc | Device | Class II | 7 |
| 26 Jan 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux… | bioMerieux, Inc. | Device | Class I | 1 |
| 24 Jan 2018 | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 | LivaNova USA Inc | Device | Class II | 1 |
| 23 Jan 2018 | bioMérieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast. | Biomerieux Inc | Device | Class II | 1 |
| 17 Jan 2018 | Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R | Olympus Corporation of the Americas | Device | Class II | 1 |
| 17 Jan 2018 | Uretero-reno fiberscope URF-P6 | Olympus Corporation of the Americas | Device | Class II | 2 |
| 5 Jan 2018 | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540 | Diamedix Corporation | Device | Class III | 2 |
| 28 Dec 2017 | 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52 mm REF number 02424652 Event 80498 | IMPLANTCAST GMBH | Device | Class II | 1 |
| 21 Dec 2017 | Custom Made Implant System with Minimum Invasive Grower (MIG) component | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 20 Dec 2017 | Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 11 Dec 2017 | Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque… | Boston Scientific Corporation | Device | Class II | 1 |
| 1 Dec 2017 | ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD | Elekta, Inc. | Device | Class II | 1 |
| 22 Nov 2017 | Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed… Event 80079 | Apollo Endosurgery Inc | Device | Class II | 1 |
| 3 Nov 2017 | Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another. | Handicare Usa Inc | Device | Class II | 2 |
| 24 Oct 2017 | Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. | Howmedica Osteonics Corp. | Device | Class II | 70 |
| 22 Sep 2017 | Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO | Guangzhou Improve Medical Instruments Co., Ltd. | Device | Class II | 1 |
| 5 Sep 2017 | Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability. Event 80510 | Forte Automation Systems Inc | Device | Class II | 1 |
| 7 Aug 2017 | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 1 Aug 2017 | GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis | Smith & Nephew, Inc. | Device | Class II | 1 |
| 31 Jul 2017 | 119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood. | ICU Medical, Inc. | Device | Class II | 53 |
| 24 Jul 2017 | Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural… | Richard Wolf GmbH | Device | Class II | 1 |
| 12 May 2017 | Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it. | Terumo Cardiovascular Systems Corp | Device | Class II | 1 |
| 18 Apr 2017 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117 | ELITech Clinical Systems SAS | Device | Class II | 1 |
| 3 Mar 2017 | ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 2 Mar 2017 | Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files. | Ortho Kinematics, Inc | Device | Class II | 1 |
| 27 Feb 2017 | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. | LIEBEL-FLARSHEIM COMPANY LLC | Device | Class II | 2 |
| 13 Feb 2017 | Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 Event 80499 | New Era Orthopaedics, LLc | Device | Class II | 1 |
| 11 Jan 2017 | Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. | Ortho Kinematics, Inc | Device | Class II | 1 |
| 21 Oct 2016 | is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjgren's syndrome and… | Euro Diagnostica AB | Device | Class III | 4 |
| 19 Oct 2016 | Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated… | Guangzhou Improve Medical Instruments Co., Ltd. | Device | Class II | 1 |
| 16 Sep 2016 | Brivo XR385, model 5215463, Digital Diagnostic Radiographic System | GE Healthcare, LLC | Device | Class II | 1 |
| 12 Aug 2016 | Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files. | Ortho Kinematics, Inc | Device | Class II | 1 |
| 14 Jul 2016 | Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva. | DRG Instruments GmbH | Device | Class II | 1 |
| 14 Feb 2016 | Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. | Euro Diagnostica AB | Device | Class II | 1 |
| 10 Oct 2013 | Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324 | Cayenne Medical Inc. | Device | Class II | 1 |
| 28 Apr 2010 | AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number… | Cayenne Medical Inc. | Device | Class II | 1 |